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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a prospective, cluster randomized trial to determine which factors influence the acquisition of the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to 26. This descriptive and interventional study will provide data to assess impact of a computerized tool upon HPV vaccine series completion. The interventional aspect of this study includes determination of patient assistance and provider support programs applicable to each woman's situation as well as the implementation of a computer software system for customized patient reminders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control, standard care for HPV vaccine | No Intervention | Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol | |
| Intervention, computer reminder system | Experimental | Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer reminder system | Behavioral | Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series |
| Measure | Description | Time Frame |
|---|---|---|
| On-time Completion of the Human Papillomavirus Vaccine Series | 32 weeks after receipt of initial vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashlesha Patel, MD, MPH | Planned Parenthood Federation of America, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of Arizona | Glendale | Arizona | 85302 | United States | ||
| Planned Parenthood of Rocky Mountains |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21381442 | Background | Centers for Disease Control and Prevention (CDC). Recommended adult immunization schedule--United States, 2011. MMWR Morb Mortal Wkly Rep. 2011 Feb 4;60(4):1-4. No abstract available. | |
| 19797775 | Background | Chao C, Velicer C, Slezak JM, Jacobsen SJ. Correlates for completion of 3-dose regimen of HPV vaccine in female members of a managed care organization. Mayo Clin Proc. 2009 Oct;84(10):864-70. doi: 10.4065/84.10.864. |
| Label | URL |
|---|---|
| Planned Parenthood Federation of America | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control, Standard Care for HPV Vaccine | Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol |
| FG001 | Intervention, Computer Reminder System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Arvada |
| Colorado |
| 80003 |
| United States |
| Planned Parenthood of Rocky Mountains | Denver | Colorado | 80218 | United States |
| Family Planning Clinic of the John H. Stroger Jr. Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Planned Parenthood of Central North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Planned Parenthood of North Carolina | Charlotte | North Carolina | 28205 | United States |
| Planned Parenthood Association of Utah | Ogden | Utah | 84403 | United States |
| Planned Parenthood Association of Utah | South Jordan | Utah | 84095 | United States |
| Planned Parenthood of Greater Northwest | Seattle | Washington | 98105 | United States |
| 19925899 | Background | Dempsey A, Cohn L, Dalton V, Ruffin M. Patient and clinic factors associated with adolescent human papillomavirus vaccine utilization within a university-based health system. Vaccine. 2010 Jan 22;28(4):989-95. doi: 10.1016/j.vaccine.2009.10.133. Epub 2009 Nov 17. |
| 19100762 | Background | Jain N, Euler GL, Shefer A, Lu P, Yankey D, Markowitz L. Human papillomavirus (HPV) awareness and vaccination initiation among women in the United States, National Immunization Survey-Adult 2007. Prev Med. 2009 May;48(5):426-31. doi: 10.1016/j.ypmed.2008.11.010. Epub 2008 Dec 6. |
| 19483128 | Background | Neubrand TP, Breitkopf CR, Rupp R, Breitkopf D, Rosenthal SL. Factors associated with completion of the human papillomavirus vaccine series. Clin Pediatr (Phila). 2009 Nov;48(9):966-9. doi: 10.1177/0009922809337534. Epub 2009 May 29. No abstract available. |
| 17971821 | Background | Orenstein WA, Mootrey GT, Pazol K, Hinman AR. Financing immunization of adults in the United States. Clin Pharmacol Ther. 2007 Dec;82(6):764-8. doi: 10.1038/sj.clpt.6100401. Epub 2007 Oct 31. |
| 19892651 | Background | Sandfort JR, Pleasant A. Knowledge, attitudes, and informational behaviors of college students in regard to the human papillomavirus. J Am Coll Health. 2009 Sep-Oct;58(2):141-9. doi: 10.1080/07448480903221368. |
| 24631099 | Derived | Patel A, Stern L, Unger Z, Debevec E, Roston A, Hanover R, Morfesis J. Staying on track: a cluster randomized controlled trial of automated reminders aimed at increasing human papillomavirus vaccine completion. Vaccine. 2014 May 1;32(21):2428-33. doi: 10.1016/j.vaccine.2014.02.095. Epub 2014 Mar 13. |
Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.
Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control, Standard Care for HPV Vaccine | Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol |
| BG001 | Intervention, Computer Reminder System | Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine. Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | On-time Completion of the Human Papillomavirus Vaccine Series | Posted | Number | participants | 32 weeks after receipt of initial vaccine |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control, Standard Care for HPV Vaccine | Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol | 0 | 185 | 0 | 180 | ||
| EG001 | Intervention, Computer Reminder System | Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine. Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series | 0 | 180 | 0 | 185 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zoe Unger, Research Program Coordinator | Planned Parenthood Federation of America | 212-261-4702 | zoe.unger@ppfa.org |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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